ABVC: Moving Forward on Several 2022 Goals to Advance Growth Strategy

By M. Marin

NASDAQ:ABVC

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2022 Goals Build on Earlier Study Results and Expanded Product Applications

ABVC BioPharma ABVC is a biopharma and medical device company developing therapies for a range of conditions focused on oncology/hematology, central nervous system (CNS) and ophthalmology. The company continues to advance its diversified drug asset portfolio, which includes lead candidates ABV-1505 and Vitargus. These lead assets are in advanced stages of development and also have the potential for multiple programs (see below). ABVC also has several assets in earlier stages of development, include recently-announced dietary supplements based on the Maitake mushroom, which has been shown to have positive impact for a number of different indications.

To advance its growth strategy, ABVC's 2022 goals include: 1) seeking a Phase III partner for its MDD study, 2) launching a self-funded pivotal trial for lead asset Vitargus®, and 3) advancing other development programs, including corneal storage media and the above-noted Maitake mushroom-based dietary supplements, among others.

Last month ABVC announced that it had received about $11.1 million from a recent offering to-date, including warrant exercise, to support its growth strategies. ABVC anticipates another potential capital raise in 2022 to ensure that it has sufficient liquidity for advancing its product development plans.

ABVC believes Vitargus has several advantages and intends to conduct studies in the U.S., Australia and potentially other markets. The company has secured a principal investigator to conduct Vitargus Phase II clinical trials in Australia. The company has also expanded its development efforts to include potential corneal storage, as noted, and other ocular procedures.

ABVC has received Taiwan Central Institutional Review Board (CIRB) approval to begin a Phase II Part 2 study of ABV-1505 for ADHD at five medical centers in Taiwan. The company also expects to receive approval to conduct a portion of the study in the UCSF Medical Center. ABVC plans to launch the study in 1Q22 and expects to complete it by the end of 2022.

ABVC recently filed new PCT (Patent Cooperation Treaty) applications for its PDC-1421-based medicines that treat MDD and ADHD. The company believes the PCT filings can help extend its global market exclusivity until about 2040-2041, if subsequent national phase applications are granted.

Plant-based therapies - minimizes potential side-effects

The company continues to seek products to add to its growing asset portfolio. In 4Q21, ABVC restructured an existing JV to expand its product portfolio. The company expects the JV to improve its ability to identify early-stage opportunities, particularly in Japan. Importantly, ABVC's products are derived primarily from plants. The company believes that plant-derived medicines can have substantial therapeutic benefits and simultaneously minimize potential side-effects compared to therapies developed from animals or chemicals.

…multiple potential applications for company's therapies

ABVC's active pipeline, the two lead products discussed earlier - ABV-1505 and Vitargus® - are in advanced stages of development, as noted, and also importantly have the potential for multiple programs. For instance, the active ingredient in ABV-1505 (and in other of the company's products under development, including ABV-1504 and ABV-1601) is PDC-1421, a botanical investigational new drug (IND). ABVC is evaluating PDC-1421's efficacy in treating MDD, as noted, as well as potentially other indications. Depression in general is a growing problem globally.

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